SPECTRALIS with HEYEX2 image management system — Class II medical device recall Z-2437-2019
Terminated recall by Heidelberg Engineering GmbH, reported 2019-09-11, distributed nationwide. Error in the default configuration which could lead to the incorrect display of patient master data.
| Recall number | Z-2437-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heidelberg Engineering GmbH, Heidelberg, N/A, Germany |
| Recall initiated | 2019-07-03 |
| Classified | 2019-08-30 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
Product
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Reason for recall
Error in the default configuration which could lead to the incorrect display of patient master data.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2437-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.